Sotatercept (ACE-011) With Lenalidomide or Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma

NCT01562405 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 11-318
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 4

Brief Summary

It is possible that the combination of lenalidomide, dexamethasone and ACE 011 may reduce or prevent the growth of cancer cells along with improving anemia and bone lesions that sometimes occur in people with multiple myeloma. This current study is the first study combining ACE 011 with lenalidomide. In this research study, the investigators are looking for the highest dose of ACE 011 that can be given with lenalidomide and dexamethasone. The investigators will also begin to collect information about the effect of the combination of ACE 011, lenalidomide and dexamethasone on multiple myeloma.

Conditions

Multiple Myeloma

Keywords

Relapsed; Refractory

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose of ACE-011

  Identify the maximum tolerated dose of ACE-011 given in combination with lenalidomide and dexamethasone in subjects with relapsed multiple myeloma

  2 years

Secondary Outcomes (4)

• Efficacy of ACE-011

  2 years

• Safety of ACE-011

  2 years

• Pharmacodynamic measures

  2 years

• Pharmacodynamic markers

  2 years

Study Arms (1)

ACE-011 (sotatercept)

EXPERIMENTAL

ACE-011, Lenalidomide or pomalidomide, Dexamethasone

Drug: ACE-011; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Pomalidomide

Interventions

ACE-011 DRUG

Injection every 28 days, dose escalation levels from 15-45 mg

Also known as: Sotatercept

ACE-011 (sotatercept)

Lenalidomide DRUG

15 to 25 mg days 1-21, given orally

Also known as: Revlimid

ACE-011 (sotatercept)

Dexamethasone DRUG

40 mg days 1,8,15,22; given orally

Also known as: Decadron

ACE-011 (sotatercept)

Pomalidomide DRUG

Pomalidomide 4 mg daily on days 1-21

Also known as: Pomalyst

ACE-011 (sotatercept)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Monoclonal plasma cells in the bone marrow \> 10% and/or presence of a biopsy-proven plasmacytoma
• Monoclonal protein present in the serum and/or urine
• Patient must have received at least 1 line of prior systemic therapy for the treatment of multiple myeloma. A line of treatment is sequential treatment without interruption for response and subsequent progression
• For participants treated with local radiotherapy with or without concomitant exposure to steroids, for pain control or management of cord/nerve root compression, two weeks must have lapsed since last date of radiotherapy, which is recommended to be a limited field. Participants who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed and two weeks have passed since the last date of therapy.
• ECOG performance status of zero to two unless decline is due to bony disease
• Not pregnant or breastfeeding

You may not qualify if:

• Participants who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Participants may not have received treatment with another investigational drug or device within 28 days prior to Day 1, or if the half life of the previous product is known, within 5 times the half life prior to dosing, whichever may be longer
• Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ACE 011, Lenalidomide or Dexamethasone
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
• History of major surgery within 30 days prior to trial initiation

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Multiple Myeloma Research Consortium: collaborator

Study Sites (4)

Emory University

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hosptial

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Scullen T, Santo L, Vallet S, Fulciniti M, Eda H, Cirstea D, Patel K, Nemani N, Yee A, Mahindra A, Raje N. Lenalidomide in combination with an activin A-neutralizing antibody: preclinical rationale for a novel anti-myeloma strategy. Leukemia. 2013 Aug;27(8):1715-21. doi: 10.1038/leu.2013.50. Epub 2013 Feb 18.

  PMID: 23417027 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

ACE-011; Lenalidomide; Dexamethasone; Calcium Dobesilate; pomalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Andrew J. Yee, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2012
• First Posted: March 23, 2012
• Study Start: May 1, 2012
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-12

Locations

US (4)